Biosecure Is in the Trump Administration’s Hands
The Trump administration has taken direct control of Biosecure, a leading biotech firm specializing in pathogen detection and vaccine platforms. New designations and implementation policies are being drafted to align the company’s operations with the administration’s bio‑security agenda. Stakeholders anticipate that regulatory pathways could be streamlined, but also fear politicized decision‑making may affect scientific independence. The move signals a broader push to integrate private biotech capabilities into national security strategies.
Comparative Efficacy and Safety of Different Surgical Strategies for Refractory Obsessive-Compulsive Disorder: Evidence From Network Meta-Analysis
A recent network meta‑analysis evaluated the comparative efficacy and safety of surgical interventions for treatment‑refractory obsessive‑compulsive disorder (OCD), focusing on ablative procedures such as gamma ventral capsulotomy and lesion‑based capsulotomy versus deep brain stimulation (DBS) targeting regions like the ventral...
Correction: GRIN2A Null Variants Confer a High Risk for Early-Onset Schizophrenia and Other Mental Disorders and Potentially Enable Precision Therapy
Researchers led by Lemke et al. report that loss‑of‑function (null) variants in the GRIN2A gene markedly increase the risk of early‑onset schizophrenia and related psychotic disorders. By integrating genome‑wide data from more than 10,000 individuals with detailed functional assays, the study...
At Least Six PDUFA Dates on FDA’s January Calendar
The FDA has posted at least six PDUFA action dates for January 2026, marking a busy decision window for pending drug applications. Among the slated reviews is the first sublingual epinephrine formulation intended for rapid treatment of allergic reactions. These...
Amgen Acquires UK Biotech Dark Blue Therapeutics
Amgen announced a $840 million acquisition of UK‑based Dark Blue Therapeutics, adding an investigational small‑molecule that degrades MLLT1/3 proteins implicated in acute myeloid leukemia (AML). The deal expands Amgen’s targeted‑protein‑degradation platform and strengthens its oncology pipeline with a novel mechanism to overcome...
Industry Outlook 2026: Trends Transitioning From 2025 Into 2026
Pharma firms widely adopted AI, IoT and digitalization in 2025, and those tools will dominate 2026. Real‑time process monitoring and predictive analytics have become competitive necessities, according to Ecolab Bioprocessing’s Laine Mello. The surge in complex biologics, cell and gene...
Deep Dive: Huntington’s at a Crossroads
The neuro‑degenerative field has gained momentum with recent disease‑modifying approvals, and uniQure’s September data showed its gene therapy could slow Huntington’s progression by 75%. However, the FDA signaled that the Phase I/II results may not satisfy the evidentiary standards for...
New Tools Turn Grain Crops Into Living Biosensors
Researchers at the Donald Danforth Plant Science Center, the University of Florida and the University of Iowa have engineered grasses, including a C4 model and major grain crops, to produce a visible purple anthocyanin pigment when exposed to specific chemicals....
Dentin Inside Wolffish Teeth Is a Rare Material: When Compressed Along Its Length—It Also Shrinks in Width
Researchers led by Prof. Ron Shahar have identified a rare auxetic material, osteodentin, inside Atlantic wolffish teeth that contracts laterally when compressed along its length. Using phase‑contrast X‑ray tomography and digital volume correlation, they measured negative Poisson’s ratios between –1...
Alumis Soars as TYK2 Drug Hits Mark in Psoriasis Trials
Alumis announced that its TYK2 inhibitor envudeucitinib met primary endpoints in two Phase 3 psoriasis trials, delivering 74% of patients achieving PASI‑75 after four months. The data suggest efficacy comparable to leading oral candidates and injectable biologics, prompting the stock to...
'Stomata In-Sight' System Allows Scientists to Watch Plants 'Breathe' In Real-Time
Researchers have unveiled the “Stomata in‑Sight” platform, a real‑time imaging system that visualizes stomatal opening and closing on living leaves. By combining high‑speed microscopy with machine‑learning algorithms, the tool records pore dynamics at sub‑second intervals. Early trials demonstrate precise measurements...
Genetic Medicines Project Gets Funding From UKRI Innovate UK and Canadian NRC IRAP
Chromatin Bioscience, Mediphage Bioceuticals, and Entos Pharmaceuticals announced a joint genetic‑medicine project funded by UKRI Innovate UK and Canada’s NRC IRAP. The partnership merges Chromatin Bioscience’s chromatinLENS synthetic‑promoter platform, Mediphage’s msDNA linear DNA technology, and Entos’s Fusogenix PLV fusion‑based delivery system....
Arrowhead Enters Obesity Chat by Doubling Tirzepatide’s Weight Loss in Combo Study
Arrowhead Pharma reported that its RNAi drug ARO‑INHBE, combined with Eli Lilly’s tirzepatide, produced roughly double the weight loss seen with tirzepatide alone in a small Phase I/IIa study. In the interim analysis, patients receiving the combo lost 9.4% of body weight...
Lilly Doubles Down With Nimbus, Paying $55M for Preclinical Obesity Drug
Eli Lilly has struck a new multi‑year collaboration with Nimbus Therapeutics, paying $55 million upfront for a preclinical oral obesity drug program that could generate up to $1.3 billion in milestones. The partnership leverages Nimbus’s AI‑driven, structure‑based design to discover small‑molecule treatments for...
From Pint to Plate, Scientists Brew up a New Way to Grow Meat
Scientists at University College London have demonstrated that spent yeast from beer brewing can be converted into bacterial cellulose scaffolds suitable for cultivated meat production. The yeast‑derived cellulose matches or exceeds the texture of conventional scaffolds while being edible and...
Researchers Sustainably Produce Triacetic Acid Lactone From Sugarcane
Researchers at the University of Illinois’s Center for Advanced Bioenergy and Bioproducts Innovation demonstrated a sustainable route to produce triacetic acid lactone (TAL) from sugarcane using fermentation followed by crystallization. By coupling experimental solubility data with the BioSTEAM simulation platform,...
Nanoparticles Show Unexpected Ability to Activate Immune System Against Melanoma
Cornell researchers have shown that ultrasmall core‑shell silica nanoparticles, dubbed "prime dots," can reprogram the tumor microenvironment of melanoma, activating innate immunity and converting immunologically "cold" tumors into "hot" ones. The study published in Nature Nanotechnology documents multiple mechanisms—including pattern‑recognition...
Inhalable Therapy Aims for One-Two Punch Against Advanced Melanoma
Columbia engineers have created BEAT, an inhalable nanotherapy that uses engineered exosomes to co‑deliver PD‑1/PD‑L1 and Wnt/β‑catenin inhibitors directly to lung metastases of melanoma. In mouse models resistant to checkpoint inhibitors, inhaled BEAT achieved superior lung retention, dramatically suppressed tumor...
Argenx Names New CEO; Van Hauwermeiren to Become Chair
Swiss biotech Argenx announced that Dr. Anneliese Klein will assume the chief executive officer role on July 1, 2026, while founder Peter Van Hauwermeiren transitions to board chair. Klein, formerly head of commercial operations at Roche’s antibody division, brings deep market expertise. Van’s move...
2026 Biotech Kickoff — a BioCentury Podcast
The BioCentury podcast kicked off 2026 by evaluating biotech trends across the United States, Europe and Asia. Funding streams are reviving, with venture capital and IPO activity picking up, while innovation in gene‑editing and mRNA remains robust. At the same...
ENA Respiratory: Boosting Prophylactic Immunity with a Pan-Viral Nasal Spray
Australian biotech ENA Respiratory has unveiled a pan‑viral nasal spray that primes the host’s innate immune system to block a broad range of upper‑respiratory viruses. Early‑stage trials reported up to a 70% drop in laboratory‑confirmed infections across influenza, RSV and...
Gene Editing in Indonesia: Can New Biotechnology Solve Old Agricultural Problems?
Indonesia faces mounting food‑security pressures as climate stress and import dependence strain its staple‑centric agriculture. Gene‑editing technologies, touted for precise, non‑transgenic trait improvements, are being positioned to boost rice, cassava and sorghum yields. Yet stakeholder interviews reveal deep skepticism, especially...
Synaptic Potentiation Requires PARP1 Activation: Prevailing Concepts Are Revisited
A recent Mol Psychiatry study reveals that poly‑ADP‑ribose polymerase 1 (PARP1) activation is indispensable for long‑term synaptic potentiation (LTP) and memory formation. The authors demonstrate a DNA‑independent activation pathway where phosphorylated Erk2 binds PARP1, exposing its NAD⁺ site and triggering poly‑ADP‑ribosylation...
Suppressor tRNAs: Giving Genetic Medicines a Broader Reach
Suppressor tRNAs are emerging as a versatile platform to overcome premature stop codons that limit many gene‑editing and RNA‑based therapies. Recent preclinical studies demonstrate that engineered tRNAs can restore full‑length protein production across diverse disease models, from muscular dystrophy to...
China Clears Mepolizumab for COPD
China’s National Medical Products Administration approved GSK’s mepolizumab (Nucala) as an add‑on maintenance therapy for adults with eosinophilic COPD, making it the first monthly biologic for the disease in the country. The decision rests on Phase III MATINEE and METREX trials...
High-Throughput Platform Enables Aptamer Discovery and Kinetic Profiling
Researchers at the Chinese Academy of Sciences unveiled SPARK‑seq, a high‑throughput platform that merges CRISPR perturbations, single‑cell multi‑omics and aptamer sequencing to map aptamer‑target interactions in native cellular contexts. In a proof‑of‑concept study, the system screened over 8,000 single cells,...
Microalgae Could Fuel Hawaiʻi's Renewable Future
Researchers at the University of Hawaiʻi at Mānoa have demonstrated how synthetic biology and CRISPR‑based metabolic engineering can boost microalgae’s production of lipids and terpenoids, key feedstocks for renewable jet fuel, bio‑based chemicals, and pharmaceuticals. The study, published in Plant...
Making Smart Decisions and Investments in Trained Staff Key to 2026 Success
Raj Puri, chief commercial officer of Argonaut Manufacturing, warns that U.S. tariffs will keep pressuring pharma manufacturers in 2026, extending costs and timelines for new or upgraded facilities. He highlights that large capital projects face uncertainty in a volatile geopolitical...
Quick Execution with Operational Integrity
Meri Beckwith, Co‑CEO of Lindus Health, outlines how 2025 trends will shape pharma in 2026. AI moved from experimental to strategic, accelerating trial design, site selection and patient matching. Decentralized trial models combined with real‑world data enable nationwide recruitment and...
FUJIFILM Irvine Scientific Becomes FUJIFILM Biosciences
FUJIFILM Irvine Scientific rebranded as FUJIFILM Biosciences on Jan. 1, 2026, aligning its name with a 55‑year legacy in cell‑culture media and bioprocessing. The change underscores the unit’s shift toward biologics manufacturing and CDMO services. Recent strategic moves include a $3 billion, 10‑year...
Advancing Pharmaceutical Quality Through Integrated Digital Systems and Collaborative Scientific Innovation
Saharsh Davuluri of Neuland Labs outlines a digital overhaul of API manufacturing, leveraging AI tools such as Merck’s Synthia and automated parallel synthesizers to design scalable processes. He envisions a fully paperless plant where electronic batch records feed directly into...
Multi-Compendial Compliance for Pharmaceutical Excipients–Part 2: A Detailed Assessment for Specification Equivalence
The article presents a technical assessment of compendial tests across the European Pharmacopoeia, USP‑NF, and Japanese Pharmacopoeia to establish specification equivalence for pharmaceutical excipients. It recommends standardizing on the Ph. Eur. method for most tests, applying the tightest acceptance criteria, and...
Nearly Every Corn Seed Planted in Colorado Is Covered in Insecticide: Lawmakers May Restrict the Chemical
Nearly every corn seed planted in Colorado is coated with a neonicotinoid insecticide, a practice that protects seedlings but also introduces the chemical into plants, soil and water. Environmental groups are drafting legislation that would ban such coatings unless farmers...
Machine Learning Drives Drug Repurposing for Neuroblastoma
Researchers at Lund University used machine learning to repurpose existing drugs for high‑risk neuroblastoma. They identified a synergistic combination of a statin and a phenothiazine that markedly slowed tumor growth in mouse models. Laboratory trials showed reduced tumor cholesterol, increased...
RO4938581, a GABAA-Α5 Negative Allosteric Modulator Rescued Behavioral and EEG Phenotypes of a Mouse Model of Dup15q Syndrome
The study shows that mice carrying the 15q duplication exhibit ~1.5‑fold elevation of GABA A‑α5 receptors in cortex, hippocampus and striatum, leading to heightened inhibitory synaptic activity and a characteristic increase in beta‑band EEG power. Chronic oral administration of the selective...
A Better Way to Detect Off-Target Genome Changes From Base Editors
St. Jude Children’s Research Hospital unveiled CHANGE‑seq‑BE, a new assay that sensitively maps off‑target activity of CRISPR base editors while using only a fraction of sequencing resources. The method, published in Nature Biotechnology, demonstrated 95.4 % on‑target specificity in an FDA‑emergency case...
Epigenetic Mechanisms Affected by Stress During Adolescence and the Increased Risk for Depression Later in Life: A Systematic Review
This systematic review examined how stressful life events during adolescence reshape epigenetic landscapes and elevate depression risk later in life. By screening 30 preclinical and clinical studies, the authors identified consistent DNA methylation and micro‑RNA changes—particularly affecting the BDNF pathway—in...
Harmeier Returns to Lead Roche Venture Fund
Roche has announced that Dr. Harmeier is returning to head its Roche Venture Fund, the pharma giant’s dedicated early‑stage investment arm. Harmeier previously led the fund from 2015 to 2020 before moving to a senior role within Roche’s corporate development...
Insilico’s Big Gain After Hong Kong Listing: Finance Report
Insilico Medicine saw its stock surge after debuting on the Hong Kong Stock Exchange, climbing roughly 45% on the first trading day. The secondary offering raised about $1.2 billion, pushing the company’s market capitalization past the $10 billion mark. The strong demand...
Best of BioCentury 2025
BioCentury released its "Best of BioCentury 2025" collection, curating the year’s most consequential biotech stories from its editorial team. The anthology spotlights breakthroughs in gene‑editing, AI‑driven drug discovery, and evolving regulatory frameworks. By distilling these seminal moments, BioCentury reinforces its mission...
Advocates Regroup After Sanders Blocks Pediatric PRV Reauthorization
Senator Bernie Sanders halted a Senate vote to reauthorize the rare pediatric disease priority review voucher (PRV) program, demanding unrelated multi‑billion‑dollar spending measures be adopted first. Although he expressed support for the PRV incentive, Sanders made clear his conditions would...
Industry Outlook 2026: Success Through Top Talent, AI Utilization, and Sustainability
Ardena US managing director Ian Bilodeau says AI is reshaping pharma by linking fragmented data and speeding product decisions. He also emphasizes that attracting and developing top talent requires challenging, impact‑focused work environments. Sustainability, highlighted by Ardena’s EcoVadis certification, is...
The Evolution of Data-First Regulatory Operations
Remco Munnik of Arcana Life Sciences says European regulators are cementing a data‑first approach, with the EMA’s electronic product database and digital submission forms becoming standard. The pharma sector is eager to embed AI for document automation and quality oversight,...
Double Cone Tumble Blender Provides Homogeneity in Heavy-Duty Applications
Charles Ross & Son introduced the DCB-5 Double Cone Tumble Blender, a five‑cubic‑foot unit designed for high‑density powder processing. The machine combines a stainless‑steel jacket, a 2 HP intensifier bar, and an integrated vacuum system to deliver repeatable homogeneity and simultaneous...
A Zero-Shot Learning Framework for Maize Cob Phenotyping
Scientists have unveiled a zero‑shot learning framework that phenotypes maize cob geometry without any model retraining. The system combines text‑guided object detection, lightweight segmentation, and calibrated trait extraction, delivering 98‑100% detection accuracy and over 0.95 correlation for trait estimates. It...
From AI to Smart Factories: How Pharma Is Preparing for 2026
Manish Garg of Hikma Pharmaceuticals highlighted how AI, personalized medicine, and smart manufacturing reshaped pharma in 2025 and set the agenda for 2026. AI accelerated drug discovery and clinical design, while niche, high‑value therapies gained prominence. Companies are regionalizing supply...
New Technique Lights up Where Drugs Go in the Body, Cell by Cell
Researchers at Scripps have unveiled vCATCH, a whole‑body imaging platform that lights up covalent drugs at single‑cell resolution in mice. By attaching a tiny chemical handle to drugs and using highly selective click‑chemistry, the method tags each bound molecule with...
HITL and HOTL: An Air Traffic Control Analogy for Agentic AI
ArisGlobal’s senior VP Jason Bryant argues that both human‑in‑the‑loop (HITL) and human‑on‑the‑loop (HOTL) remain essential for deploying agentic AI in pharma. He uses an air‑traffic‑control analogy, portraying AI agents as aircraft and the orchestration layer as air‑traffic management. Bryant stresses...
Legends Lost: Baltimore, Rutter Among Biotech’s Greats to Depart in 2025
The biotech community mourned the loss of several iconic figures in 2025, including Nobel laureate David Baltimore and industry pioneer Rutter. Their careers spanned groundbreaking scientific discoveries, the founding of biotech firms, and the cultivation of global research ecosystems. The...
Industry Outlook 2026: The Impact of Novel Therapies
In 2025 the pharmaceutical sector saw a surge of novel therapies, notably next‑generation biologics such as bispecifics, fusion proteins, multi‑specifics, and a wave of antibody‑drug conjugates (ADCs). A breakthrough sub‑category, antibody‑oligo conjugates (AOCs), gained traction for muscular dystrophy, highlighted by...